The Union Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, to simplify regulatory requirements, reduce compliance costs and enable faster market access for eligible medical devices. The proposed changes focus on outsourced sterilisation, testing fees and clinical investigation requirements.
Easier Compliance for Outsourced Sterilisation
Under the proposed amendment to Rule 44, manufacturers using licensed third-party sterilisation facilities will no longer need a separate loan licence, provided the sterilisation facility holds a valid licence under the Medical Devices Rules, 2017.
As a result, manufacturers could face fewer documentation requirements, shorter approval timelines and lower compliance costs. The change would also allow companies to make better use of specialised sterilisation facilities.
Uniform Testing Fees
The government has also proposed introducing a Ninth Schedule with uniform fees for testing medical devices at Medical Device Testing Laboratories. This move aims to standardise testing charges and reduce variations between laboratories.
According to ETLegalWorld, predictable testing fees could reduce ambiguity and disputes while ensuring greater transparency and consistency for manufacturers and importers.
Faster Access for Internationally Approved Devices
Furthermore, the proposed amendment to Rule 63 would recognise the European Union as a stringent regulatory jurisdiction for certain medical devices without predicate devices. Currently, the framework recognises the United States, United Kingdom, Australia, Canada and Japan.
Consequently, eligible devices already approved in the European Union could potentially enter the Indian market faster, with fewer regulatory requirements and shorter approval timelines.
Towards a More Efficient MedTech Regulatory Framework
Overall, the proposed amendments seek to make India’s medical device regulatory system more predictable and industry-friendly. By reducing unnecessary compliance requirements while maintaining regulatory oversight, the government aims to encourage innovation, lower costs and improve the timely availability of advanced medical technologies in India.